AccessGUDID - DEVICE: Powered Loading System (PLS) (Wheelchair, PM) (00810050862288)

GUDID

Device Identifier (DI) Information

Brand Name: Powered Loading System (PLS) (Wheelchair, PM)
Version or Model: 21-10040-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LIFEPORT, LLC

Primary DI Number: 00810050862288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 556196210 *Terms of Use

Device Description: AIR STAIR ASSY NO MOD G 3-5 * (PLS) (WHEELCHAIR)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
41603	Assistive automobile wheelchair/occupant lift	An electrically-powered hoist designed for personal use to allow the user seated in his or her wheelchair to get into or out of their motor vehicle, e.g., a car or van, which is built or adapted for use by a person with a disability. It allows the wheelchair occupant to remain seated in the wheelchair while driving or riding in the motor vehicle. The device may be attached to the vehicle and be powered by the vehicle's electrical supply.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PCE	Permanently Mounted Wheelchair Platform Lift

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 77c30e12-bb4b-4df3-b9bc-ab2c9af5dc94
Public Version Date: January 13, 2023
Public Version Number: 1
DI Record Publish Date: January 05, 2023